27-2-12.32. Biomarker testing coverage.
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A. In accordance with federal law, the secretary shall adopt and promulgate rules that provide medical assistance coverage for enrollees to receive biomarker testing.
B. A medical assistance plan providing coverage pursuant to this section shall be for the purposes of diagnosis, treatment, appropriate management or ongoing monitoring of an enrollee's disease or condition when the test is supported by medical and scientific evidence, including:
(1)labeled indications for a United States food and drug administration- approved or -cleared test;
(2)indicated tests for a United States food and drug administration-approved drug;
(3)warnings and precautions on United States food and drug administration labels;
(4)federal centers for medicare and medicaid services national coverage determinations or medicare administrative contractor local coverage determinations; or
(5)nationally recognized clinical practice guidelines.
C. Medicaid contractors delivering services to enrollees shall provide biomarker testing at the same scope, duration and frequency as the medical assistance plan otherwise provides to enrollees.
D. A medical assistance plan providing coverage for biomarker testing pursuant to this section shall ensure that:
(1)coverage is provided in a manner that limits disruptions in care, including coverage for multiple biopsies or biospecimen samples; and
(2)a patient and a practitioner who prescribes biomarker testing have clear, readily accessible and convenient processes to request an appeal of a benefit denial by the insurer and that those processes are accessible on the medical assistance division of the department's website.
E. As used in this section:
(1)"biomarker" means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacologic responses to a specific therapeutic intervention, including known gene- drug interactions for medications being considered for use or already being administered. "Biomarker" includes gene mutations, characteristics of genes or protein expression;
(2)"biomarker testing" means analysis of a patient's tissue, blood or other biospecimen for the presence of a biomarker and includes single-analyte tests, multi- plex panel tests, protein expression and whole exome, whole genome and whole transcriptome sequencing; and
(3)"nationally recognized clinical practice guidelines" means evidence-based clinical practice guidelines that are:
(a)developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and with a conflict-of-interest policy; and
(b)used to establish standards of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options and include recommendations intended to optimize patient care.
History: Laws 2023, ch. 138, § 2.